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A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal Cancer With Minimal Residual Disease Following Definitive Surgery and Chemotherapy (EMPIRE)

NCT07058012 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2026-05-15

No results posted yet for this study

Summary

The NSABP FC-13 study is being done to determine if using immunotherapies alone or in combination with other drugs will delay or prevent colorectal cancer from coming back in patients with colorectal cancer who are ctDNA-positive after their treatment. Immunotherapeutic drugs (immunotherapies) act on different proteins on the surface of cells of the immune system and trigger the immune system to destroy cancer cells. The drugs being studied in NSABP FC-13 are cemiplimab, fianlimab, and REGN7075.

Conditions

  • Colo-rectal Cancer

Interventions

DRUG

cemiplimab + REGN7075

Cemiplimab 350mg + REGN7075 2700mg intravenously

OTHER

ctDNA testing

Eligible patients using results for ctDNA-positivity as obtained from a commercial assay run in any CLIA-certified lab will proceed to enrollment and begin treatment. All patients will have confirmation of ctDNA-positivity via the Signatera\^TM assay (Clinical Trial Assay), but treatment may proceed while awaiting confirmatory results.

DRUG

Cemiplimab

Cemiplimab 350mg intravenously

DRUG

cemiplimab plus fianlimab

Cemiplimab 350mg + Fianlimab 1600mg intravenously

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-17
Primary Completion
2029-04-17
Completion
2029-06-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07058012 on ClinicalTrials.gov